NDC 65162-770

Ibuprofen Pain Reliever/Fever Reducer

Ibuprofen

Ibuprofen Pain Reliever/Fever Reducer is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Ibuprofen.

Product ID65162-770_04959a36-0476-45fa-98c9-319d64b5cb14
NDC65162-770
Product TypeHuman Otc Drug
Proprietary NameIbuprofen Pain Reliever/Fever Reducer
Generic NameIbuprofen
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2011-12-23
Marketing CategoryANDA / ANDA
Application NumberANDA202300
Labeler NameAmneal Pharmaceuticals LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-770-02

1 BOTTLE in 1 CARTON (65162-770-02) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2011-12-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-770-11 [65162077011]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA202300
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-23

NDC 65162-770-50 [65162077050]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA202300
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-23

NDC 65162-770-69 [65162077069]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA202300
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-23

NDC 65162-770-02 [65162077002]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA202300
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-23

NDC 65162-770-08 [65162077008]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA202300
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-23
Marketing End Date2015-01-09

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:5f27dd3f-c735-417b-95e6-26dc5aae5a7a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310964
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Ibuprofen Pain Reliever/Fever Reducer" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    69168-338Ibuprofen Pain reliever/fever reducerIbuprofen Pain reliever/fever reducer
    65162-770Ibuprofen Pain Reliever/Fever ReducerIbuprofen Pain Reliever/Fever Reducer
    65162-356Ibuprofen Pain Reliever/Fever ReducerIbuprofen Pain Reliever/Fever Reducer
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
    0113-7131basic care ibuprofenIbuprofen
    0113-7517basic care ibuprofenIbuprofen
    0113-7604Basic Care IbuprofenIbuprofen
    0121-0917Childrens IbuprofenIbuprofen
    0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
    0113-2461Good Sense Childrens IbuprofenIbuprofen
    0113-0057Good Sense ibuprofenibuprofen
    0113-0074Good Sense ibuprofenIbuprofen
    0113-0166good sense ibuprofenIbuprofen
    0113-0298good sense ibuprofenIbuprofen
    0113-0461Good Sense ibuprofenIbuprofen
    0113-0517Good Sense ibuprofenIbuprofen
    0113-0604good sense ibuprofenIbuprofen
    0113-0647good sense ibuprofenIbuprofen
    0113-0660Good Sense IbuprofenIbuprofen
    0113-0685Good Sense IbuprofenIbuprofen
    0113-0897good sense ibuprofenIbuprofen
    0113-1212Good Sense IbuprofenIbuprofen
    0113-4501good sense ibuprofenibuprofen
    0113-0040Good Sense Infants IbuprofenIbuprofen

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.